Trial Outcomes & Findings for A Phase 2 Safety and Immunogenicity Study for an Anthrax Vaccine Using 3 Schedules and Two Dose Levels (NCT NCT01770743)

Last Updated: 2024-03-18

Results Overview

Immunogenicity measured by the lower bound (LB) of the 95% confidence intervals (CIs) for the proportion of subjects in each study arm with Day 63 TNA 50% neutralization factor (NF50) values greater than or equal to threshold

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

168 participants

Primary outcome timeframe

Day 63

Results posted on

2024-03-18

Participant Flow

Participants were enrolled from 16 January 2013 to 14 November 2013 at 4 medical centers in the United States.

All 168 enrolled participants who met eligibility criteria were dosed.

Participant milestones

Participant milestones
Measure	AV7909 (Day 0 and 14) Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14 AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant	AV7909 (Day 0 and 28) Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28 AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant	AV7909 (Day 0, 14, and 28) Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28 AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant	AV7909 Reduced Dose Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28 AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant	BioThrax Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28 BioThrax
Overall Study STARTED	44	34	23	44	23
Overall Study Treated	44	34	23	44	23
Overall Study COMPLETED	42	31	22	42	21
Overall Study NOT COMPLETED	2	3	1	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	AV7909 (Day 0 and 14) Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14 AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant	AV7909 (Day 0 and 28) Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28 AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant	AV7909 (Day 0, 14, and 28) Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28 AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant	AV7909 Reduced Dose Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28 AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant	BioThrax Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28 BioThrax
Overall Study Adverse Event	1	0	0	0	0
Overall Study Withdrawal by Subject	0	0	1	1	1
Overall Study Lost to Follow-up	0	2	0	0	1
Overall Study Sponsor Terminated Subject	1	0	0	1	0
Overall Study Moving Out of State	0	1	0	0	0

Baseline Characteristics

A Phase 2 Safety and Immunogenicity Study for an Anthrax Vaccine Using 3 Schedules and Two Dose Levels

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AV7909 (Day 0 and 14) n=44 Participants Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14 AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant	AV7909 (Day 0 and 28) n=34 Participants Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28 AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant	AV7909 (Day 0, 14, and 28) n=23 Participants Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28 AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant	AV7909 Reduced Dose n=44 Participants Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28 AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant	BioThrax n=23 Participants Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28 BioThrax	Total n=168 Participants Total of all reporting groups
Age, Continuous	33.4 years STANDARD_DEVIATION 9.0 • n=5 Participants	32.7 years STANDARD_DEVIATION 9.7 • n=7 Participants	29.7 years STANDARD_DEVIATION 10.2 • n=5 Participants	32.8 years STANDARD_DEVIATION 9.2 • n=4 Participants	32.5 years STANDARD_DEVIATION 10.4 • n=21 Participants	32.5 years STANDARD_DEVIATION 9.5 • n=10 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	4 Participants n=10 Participants
Age, Categorical Between 18 and 65 years	44 Participants n=5 Participants	32 Participants n=7 Participants	22 Participants n=5 Participants	44 Participants n=4 Participants	22 Participants n=21 Participants	164 Participants n=10 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	17 Participants n=7 Participants	11 Participants n=5 Participants	22 Participants n=4 Participants	11 Participants n=21 Participants	83 Participants n=10 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	17 Participants n=7 Participants	12 Participants n=5 Participants	22 Participants n=4 Participants	12 Participants n=21 Participants	85 Participants n=10 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	2 Participants n=21 Participants	12 Participants n=10 Participants
Race (NIH/OMB) White	40 Participants n=5 Participants	33 Participants n=7 Participants	20 Participants n=5 Participants	40 Participants n=4 Participants	21 Participants n=21 Participants	154 Participants n=10 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants	7 Participants n=7 Participants	4 Participants n=5 Participants	5 Participants n=4 Participants	4 Participants n=21 Participants	29 Participants n=10 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	35 Participants n=5 Participants	27 Participants n=7 Participants	19 Participants n=5 Participants	39 Participants n=4 Participants	19 Participants n=21 Participants	139 Participants n=10 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Region of Enrollment United States	44 participants n=5 Participants	34 participants n=7 Participants	23 participants n=5 Participants	44 participants n=4 Participants	23 participants n=21 Participants	168 participants n=10 Participants

PRIMARY outcome

Timeframe: Day 63

Population: Per-protocol Population at Day 63 (randomized subjects who did not have any deviation of 1) history of anthrax vaccination; 2) missing or out of window vaccination at Day 14 or 28; 3) incorrect IMP dose at one or more visits; 4) IMP dose associated with a temperature excursion; 5) prohibited medications; or 6) missing Day 63 immunogenicity data).

Outcome measures

Outcome measures
Measure	AV7909 (Day 0 and 14) n=37 Participants Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14 AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant	AV7909 (Day 0 and 28) n=27 Participants Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28 AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant	AV7909 (Day 0, 14, and 28) n=18 Participants Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28 AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant	AV7909 Reduced Dose n=41 Participants Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28 AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant	BioThrax n=21 Participants Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28 BioThrax
Toxin Neutralizing Antibody (TNA) Level at Day 63	56.8 percentage of participants Interval 39.5 to 72.9	100 percentage of participants Interval 87.2 to 100.0	100 percentage of participants Interval 81.5 to 100.0	90.2 percentage of participants Interval 76.9 to 97.3	52.4 percentage of participants Interval 29.8 to 74.3

PRIMARY outcome

Timeframe: From the time of the first immunization on Day 0 through Day 84

Population: Safety Population (subjects who received at least one dose of IMP)

Incidence of adverse events (including assessment of symptoms, physical exam findings, clinical laboratory tests, and vital signs) from the time of the first immunization on Day 0 through Day 84

Outcome measures

Outcome measures
Measure	AV7909 (Day 0 and 14) n=44 Participants Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14 AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant	AV7909 (Day 0 and 28) n=34 Participants Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28 AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant	AV7909 (Day 0, 14, and 28) n=23 Participants Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28 AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant	AV7909 Reduced Dose n=44 Participants Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28 AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant	BioThrax n=23 Participants Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28 BioThrax
Incidence of Adverse Events	36 participants	26 participants	17 participants	35 participants	15 participants

PRIMARY outcome

Timeframe: From the time of the first immunization on Day 0 through the 12-month safety follow-up telephone call following the last scheduled vaccination

Population: Safety Population (subjects who received at least one dose of IMP)

Incidence of serious adverse events, from the time of the first immunization on Day 0 through the 12-month safety follow-up telephone call following the last scheduled vaccination

Outcome measures

Outcome measures
Measure	AV7909 (Day 0 and 14) n=44 Participants Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14 AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant	AV7909 (Day 0 and 28) n=34 Participants Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28 AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant	AV7909 (Day 0, 14, and 28) n=23 Participants Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28 AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant	AV7909 Reduced Dose n=44 Participants Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28 AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant	BioThrax n=23 Participants Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28 BioThrax
Incidence of Serious Adverse Events	2 participants	0 participants	0 participants	0 participants	1 participants

PRIMARY outcome

Timeframe: For 7 days following each vaccination on Days 0, 14, 28

Population: Safety Population (subjects who received at least one dose of IMP)

Incidence of solicited systemic reactions and solicited injection site reactions each day for 7 days following each vaccination using subject e-diaries by severity. Reactions were graded using the following scale (note, for redness and swelling, the diameter \[greater of two perpendicular measurements\] was assessed by the subject using an injection site measurement tool): Grade 0 (Absent): Symptom not present; Grade 1 (Mild): Symptom present but does not interfere with activities of daily living, or affected area (redness, swelling) measures \<3 cm; Grade 2 (Moderate): Symptom causes some interference with activities of daily living, or affected area (redness, swelling) measures 3 - 10 cm; Grade 3 (Severe): Symptom prevents activities of daily living or requires treatment, or affected area (redness, swelling) measures \> 10 cm. For each reaction, subjects are counted once across all vaccinations at the highest reported level of severity.

Outcome measures

Outcome measures
Measure	AV7909 (Day 0 and 14) n=44 Participants Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14 AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant	AV7909 (Day 0 and 28) n=34 Participants Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28 AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant	AV7909 (Day 0, 14, and 28) n=23 Participants Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28 AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant	AV7909 Reduced Dose n=44 Participants Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28 AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant	BioThrax n=23 Participants Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28 BioThrax
Incidence of Reactogenicity By Severity Fatigue/Tiredness Grade 1	11 participants	17 participants	14 participants	19 participants	8 participants
Incidence of Reactogenicity By Severity Fatigue/Tiredness Grade 2	6 participants	5 participants	1 participants	2 participants	3 participants
Incidence of Reactogenicity By Severity Fever Grade 3	2 participants	0 participants	0 participants	0 participants	0 participants
Incidence of Reactogenicity By Severity Warmth Grade 3	0 participants	0 participants	1 participants	0 participants	0 participants
Incidence of Reactogenicity By Severity Fatigue/Tiredness Grade 3	3 participants	0 participants	1 participants	0 participants	0 participants
Incidence of Reactogenicity By Severity Muscle Ache Grade 1	25 participants	19 participants	13 participants	27 participants	13 participants
Incidence of Reactogenicity By Severity Muscle Ache Grade 2	6 participants	6 participants	7 participants	9 participants	3 participants
Incidence of Reactogenicity By Severity Muscle Ache Grade 3	2 participants	0 participants	0 participants	0 participants	0 participants
Incidence of Reactogenicity By Severity Headache Grade 1	10 participants	15 participants	9 participants	14 participants	8 participants
Incidence of Reactogenicity By Severity Headache Grade 2	7 participants	3 participants	6 participants	7 participants	1 participants
Incidence of Reactogenicity By Severity Headache Grade 3	4 participants	0 participants	0 participants	0 participants	0 participants
Incidence of Reactogenicity By Severity Fever Grade 1	0 participants	0 participants	0 participants	0 participants	0 participants
Incidence of Reactogenicity By Severity Fever Grade 2	0 participants	1 participants	0 participants	0 participants	0 participants
Incidence of Reactogenicity By Severity Warmth Grade 1	17 participants	15 participants	11 participants	14 participants	11 participants
Incidence of Reactogenicity By Severity Warmth Grade 2	1 participants	0 participants	2 participants	2 participants	0 participants
Incidence of Reactogenicity By Severity Tenderness Grade 1	31 participants	27 participants	17 participants	29 participants	14 participants
Incidence of Reactogenicity By Severity Tenderness Grade 2	11 participants	6 participants	5 participants	9 participants	5 participants
Incidence of Reactogenicity By Severity Tenderness Grade 3	0 participants	0 participants	0 participants	0 participants	0 participants
Incidence of Reactogenicity By Severity Itching Grade 1	5 participants	3 participants	3 participants	10 participants	5 participants
Incidence of Reactogenicity By Severity Itching Grade 2	2 participants	0 participants	0 participants	0 participants	0 participants
Incidence of Reactogenicity By Severity Itching Grade 3	0 participants	0 participants	0 participants	0 participants	0 participants
Incidence of Reactogenicity By Severity Pain Grade 1	30 participants	29 participants	15 participants	29 participants	14 participants
Incidence of Reactogenicity By Severity Pain Grade 2	9 participants	2 participants	7 participants	8 participants	6 participants
Incidence of Reactogenicity By Severity Pain Grade 3	1 participants	0 participants	0 participants	0 participants	0 participants
Incidence of Reactogenicity By Severity Arm Motion Limitation Grade 1	21 participants	15 participants	11 participants	17 participants	8 participants
Incidence of Reactogenicity By Severity Arm Motion Limitation Grade 2	11 participants	9 participants	7 participants	11 participants	5 participants
Incidence of Reactogenicity By Severity Arm Motion Limitation Grade 3	1 participants	0 participants	0 participants	0 participants	0 participants
Incidence of Reactogenicity By Severity Redness Grade 1	6 participants	5 participants	3 participants	10 participants	8 participants
Incidence of Reactogenicity By Severity Redness Grade 2	2 participants	1 participants	1 participants	1 participants	0 participants
Incidence of Reactogenicity By Severity Redness Grade 3	0 participants	0 participants	0 participants	0 participants	0 participants
Incidence of Reactogenicity By Severity Lump Grade 1	13 participants	6 participants	9 participants	16 participants	10 participants
Incidence of Reactogenicity By Severity Lump Grade 2	0 participants	0 participants	0 participants	0 participants	0 participants
Incidence of Reactogenicity By Severity Lump Grade 3	0 participants	0 participants	0 participants	0 participants	0 participants
Incidence of Reactogenicity By Severity Swelling Grade 1	12 participants	7 participants	7 participants	14 participants	7 participants
Incidence of Reactogenicity By Severity Swelling Grade 2	0 participants	0 participants	2 participants	0 participants	1 participants
Incidence of Reactogenicity By Severity Swelling Grade 3	0 participants	0 participants	0 participants	0 participants	0 participants
Incidence of Reactogenicity By Severity Bruise Grade 1	4 participants	6 participants	2 participants	8 participants	4 participants
Incidence of Reactogenicity By Severity Bruise Grade 2	0 participants	0 participants	0 participants	0 participants	0 participants
Incidence of Reactogenicity By Severity Bruise Grade 3	0 participants	0 participants	0 participants	0 participants	0 participants

PRIMARY outcome

Timeframe: From the time of first immunization on Day 0 to Day 84

Population: Safety Population (subjects who received at least one dose of IMP)

Incidence of clinical laboratory abnormalities throughout the study (up to Day 84). Clinical laboratory abnormalities are presented as the total of Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), and Grade 4 (potentially life-threatening) abnormalities according to criteria adapted from the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research: Guidance for Industry. Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (September 2007). Within each laboratory parameter, subjects are counted once for their most severe occurrence of clinical laboratory abnormality.

Outcome measures

Outcome measures
Measure	AV7909 (Day 0 and 14) n=44 Participants Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14 AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant	AV7909 (Day 0 and 28) n=34 Participants Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28 AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant	AV7909 (Day 0, 14, and 28) n=23 Participants Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28 AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant	AV7909 Reduced Dose n=44 Participants Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28 AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant	BioThrax n=23 Participants Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28 BioThrax
Incidence of Clinical Laborabory Abnormalities Leukocytes	8 participants	4 participants	3 participants	3 participants	0 participants
Incidence of Clinical Laborabory Abnormalities Hemoglobin	39 participants	29 participants	20 participants	42 participants	19 participants
Incidence of Clinical Laborabory Abnormalities Neutrophils	2 participants	1 participants	1 participants	3 participants	0 participants
Incidence of Clinical Laborabory Abnormalities Lymphocytes	0 participants	1 participants	4 participants	2 participants	0 participants
Incidence of Clinical Laborabory Abnormalities Aspartate Aminotransferase	3 participants	2 participants	3 participants	4 participants	1 participants
Incidence of Clinical Laborabory Abnormalities Alanine Aminotransferase	2 participants	3 participants	1 participants	3 participants	2 participants
Incidence of Clinical Laborabory Abnormalities Glucose	9 participants	7 participants	8 participants	13 participants	2 participants
Incidence of Clinical Laborabory Abnormalities Glucose Fasting	0 participants	0 participants	1 participants	0 participants	0 participants
Incidence of Clinical Laborabory Abnormalities Bilirubin	1 participants	2 participants	1 participants	0 participants	1 participants
Incidence of Clinical Laborabory Abnormalities Blood Urea Nitrogen	1 participants	0 participants	1 participants	1 participants	0 participants
Incidence of Clinical Laborabory Abnormalities Urine Glucose	2 participants	1 participants	0 participants	0 participants	1 participants
Incidence of Clinical Laborabory Abnormalities Urine Protein	16 participants	10 participants	5 participants	13 participants	6 participants
Incidence of Clinical Laborabory Abnormalities Urine Erythrocytes	11 participants	5 participants	4 participants	7 participants	8 participants

PRIMARY outcome

Timeframe: From the time of the first immunization on Day 0 through the 12-month safety follow-up telephone call following the last scheduled vaccination

Population: Safety Population (subjects who received at least one dose of IMP)

Incidence of immunologically significant adverse events of special interest as defined by the Center for Biologics Evaluation and Research from the time of the first immunization on Day 0 through the 12-month safety follow-up telephone call following the last scheduled vaccination

Outcome measures

Outcome measures
Measure	AV7909 (Day 0 and 14) n=44 Participants Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14 AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant	AV7909 (Day 0 and 28) n=34 Participants Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28 AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant	AV7909 (Day 0, 14, and 28) n=23 Participants Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28 AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant	AV7909 Reduced Dose n=44 Participants Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28 AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant	BioThrax n=23 Participants Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28 BioThrax
Incidence of Immunologically Significant Adverse Events of Special Interest	0 participants	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Day 42

Immunogenicity measured by the percentage of subjects in each study arm with Day 42 TNA NF50 values greater than or equal to threshold

Outcome measures

Outcome measures
Measure	AV7909 (Day 0 and 14) n=37 Participants Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14 AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant	AV7909 (Day 0 and 28) n=26 Participants Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28 AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant	AV7909 (Day 0, 14, and 28) n=18 Participants Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28 AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant	AV7909 Reduced Dose n=41 Participants Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28 AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant	BioThrax n=20 Participants Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28 BioThrax
TNA Level at Day 42	86.5 percentage of participants Interval 71.2 to 95.5	100 percentage of participants Interval 86.8 to 100.0	94.4 percentage of participants Interval 72.7 to 99.9	97.6 percentage of participants Interval 87.1 to 99.9	70.0 percentage of participants Interval 45.7 to 88.1

SECONDARY outcome

Timeframe: Day 28

Immunogenicity measured by the percentage of subjects with Day 28 TNA NF50 values greater than or equal to threshold

Outcome measures

Outcome measures
Measure	AV7909 (Day 0 and 14) n=37 Participants Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14 AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant	AV7909 (Day 0 and 28) n=27 Participants Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28 AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant	AV7909 (Day 0, 14, and 28) n=18 Participants Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28 AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant	AV7909 Reduced Dose n=41 Participants Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28 AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant	BioThrax n=21 Participants Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28 BioThrax
TNA Level at Day 28	83.8 percentage of participants Interval 68.0 to 93.8	11.1 percentage of participants Interval 2.4 to 29.2	94.4 percentage of participants Interval 72.7 to 99.9	63.4 percentage of participants Interval 46.9 to 77.9	47.6 percentage of participants Interval 25.7 to 70.2

SECONDARY outcome

Timeframe: Up to Day 84

Immunogenicity measured by the percentage of subjects who have seroconverted (defined as a 4-fold increase over Day 0 in TNA NF50 value) at Days 21, 28, 35, 42, 49, 63, and 84

Outcome measures

Outcome measures
Measure	AV7909 (Day 0 and 14) n=37 Participants Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14 AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant	AV7909 (Day 0 and 28) n=27 Participants Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28 AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant	AV7909 (Day 0, 14, and 28) n=18 Participants Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28 AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant	AV7909 Reduced Dose n=41 Participants Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28 AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant	BioThrax n=21 Participants Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28 BioThrax
TNA Seroconversion Rate Day 21	63.9 percentage of participants Interval 46.2 to 79.2	55.6 percentage of participants Interval 35.3 to 74.5	77.8 percentage of participants Interval 52.4 to 93.6	22.0 percentage of participants Interval 10.6 to 37.6	14.3 percentage of participants Interval 3.0 to 36.3
TNA Seroconversion Rate Day 28	97.3 percentage of participants Interval 85.8 to 99.9	40.7 percentage of participants Interval 22.4 to 61.2	94.4 percentage of participants Interval 72.7 to 99.9	92.7 percentage of participants Interval 80.1 to 98.5	57.1 percentage of participants Interval 34.0 to 78.2
TNA Seroconversion Rate Day 35	97.1 percentage of participants Interval 85.1 to 99.9	96.3 percentage of participants Interval 81.0 to 99.9	100 percentage of participants Interval 81.5 to 100.0	95.0 percentage of participants Interval 83.1 to 99.4	66.7 percentage of participants Interval 41.0 to 86.7
TNA Seroconversion Rate Day 42	97.3 percentage of participants Interval 85.8 to 99.9	100 percentage of participants Interval 86.8 to 100.0	100 percentage of participants Interval 81.5 to 100.0	100 percentage of participants Interval 91.4 to 100.0	95.0 percentage of participants Interval 75.1 to 99.9
TNA Seroconversion Rate Day 63	86.5 percentage of participants Interval 71.2 to 95.5	100 percentage of participants Interval 87.2 to 100.0	100 percentage of participants Interval 81.5 to 100.0	97.6 percentage of participants Interval 87.1 to 99.9	85.7 percentage of participants Interval 63.7 to 97.0
TNA Seroconversion Rate Day 84	75.7 percentage of participants Interval 58.8 to 88.2	100 percentage of participants Interval 86.8 to 100.0	100 percentage of participants Interval 81.5 to 100.0	97.4 percentage of participants Interval 86.5 to 99.9	63.2 percentage of participants Interval 38.4 to 83.7
TNA Seroconversion Rate Day 49	91.9 percentage of participants Interval 78.1 to 98.3	100 percentage of participants Interval 85.8 to 100.0	100 percentage of participants Interval 81.5 to 100.0	97.6 percentage of participants Interval 87.1 to 99.9	95.0 percentage of participants Interval 75.1 to 99.9

Adverse Events

AV7909 (Day 0 and 14)

Serious events: 2 serious events

Other events: 32 other events

Deaths: 0 deaths

AV7909 (Day 0 and 28)

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

AV7909 (Day 0, 14, and 28)

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

AV7909 Reduced Dose

Serious events: 0 serious events

Other events: 27 other events

Deaths: 0 deaths

BioThrax

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	AV7909 (Day 0 and 14) n=44 participants at risk Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14 AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant	AV7909 (Day 0 and 28) n=34 participants at risk Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28 AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant	AV7909 (Day 0, 14, and 28) n=23 participants at risk Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28 AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant	AV7909 Reduced Dose n=44 participants at risk Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28 AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant	BioThrax n=23 participants at risk Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28 BioThrax
Respiratory, thoracic and mediastinal disorders Atelectasis neonatal	2.3% 1/44 • Number of events 1 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	0.00% 0/34 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	0.00% 0/23 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	0.00% 0/44 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	0.00% 0/23 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.
Infections and infestations Cellulitis	2.3% 1/44 • Number of events 1 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	0.00% 0/34 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	0.00% 0/23 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	0.00% 0/44 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	0.00% 0/23 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.
Infections and infestations Pyelonephritis	0.00% 0/44 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	0.00% 0/34 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	0.00% 0/23 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	0.00% 0/44 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	4.3% 1/23 • Number of events 1 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal neoplasm	2.3% 1/44 • Number of events 1 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	0.00% 0/34 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	0.00% 0/23 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	0.00% 0/44 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	0.00% 0/23 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.

Other adverse events

Other adverse events
Measure	AV7909 (Day 0 and 14) n=44 participants at risk Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14 AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant	AV7909 (Day 0 and 28) n=34 participants at risk Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28 AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant	AV7909 (Day 0, 14, and 28) n=23 participants at risk Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28 AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant	AV7909 Reduced Dose n=44 participants at risk Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28 AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant	BioThrax n=23 participants at risk Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28 BioThrax
Cardiac disorders Bradycardia	4.5% 2/44 • Number of events 2 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	0.00% 0/34 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	4.3% 1/23 • Number of events 1 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	11.4% 5/44 • Number of events 7 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	0.00% 0/23 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.
Infections and infestations Nasopharyngitis	15.9% 7/44 • Number of events 7 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	8.8% 3/34 • Number of events 3 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	0.00% 0/23 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	4.5% 2/44 • Number of events 2 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	4.3% 1/23 • Number of events 1 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.
Investigations Blood pressure diastolic decreased	11.4% 5/44 • Number of events 5 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	8.8% 3/34 • Number of events 4 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	8.7% 2/23 • Number of events 2 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	13.6% 6/44 • Number of events 10 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	0.00% 0/23 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.
Infections and infestations Upper respiratory tract infection	22.7% 10/44 • Number of events 10 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	14.7% 5/34 • Number of events 5 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	8.7% 2/23 • Number of events 2 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	15.9% 7/44 • Number of events 8 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	8.7% 2/23 • Number of events 2 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.
Infections and infestations Urinary tract infection	0.00% 0/44 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	2.9% 1/34 • Number of events 1 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	8.7% 2/23 • Number of events 2 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	2.3% 1/44 • Number of events 1 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	0.00% 0/23 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.
Infections and infestations Viral infection	2.3% 1/44 • Number of events 1 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	5.9% 2/34 • Number of events 3 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	0.00% 0/23 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	4.5% 2/44 • Number of events 2 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	0.00% 0/23 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.
Infections and infestations Vulvovaginal mycotic infection	0.00% 0/22 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	0.00% 0/17 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	0.00% 0/11 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	0.00% 0/22 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	18.2% 2/11 • Number of events 2 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.
Investigations AST increased	4.5% 2/44 • Number of events 2 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	5.9% 2/34 • Number of events 3 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	4.3% 1/23 • Number of events 1 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	2.3% 1/44 • Number of events 1 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	0.00% 0/23 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.
Investigations Blood pressure increased	6.8% 3/44 • Number of events 4 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	0.00% 0/34 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	0.00% 0/23 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	0.00% 0/44 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	0.00% 0/23 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.
Investigations Heart rate decreased	2.3% 1/44 • Number of events 2 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	11.8% 4/34 • Number of events 6 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	0.00% 0/23 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	2.3% 1/44 • Number of events 1 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	8.7% 2/23 • Number of events 2 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.
Investigations Protein urine present	0.00% 0/44 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	0.00% 0/34 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	0.00% 0/23 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	0.00% 0/44 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	8.7% 2/23 • Number of events 2 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.
Investigations Red blood cells urine positive	4.5% 2/44 • Number of events 3 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	0.00% 0/34 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	0.00% 0/23 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	0.00% 0/44 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	17.4% 4/23 • Number of events 5 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.
Investigations Respiratory rate increased	13.6% 6/44 • Number of events 14 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	5.9% 2/34 • Number of events 4 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	17.4% 4/23 • Number of events 9 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	22.7% 10/44 • Number of events 13 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	8.7% 2/23 • Number of events 2 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.
Musculoskeletal and connective tissue disorders Back pain	4.5% 2/44 • Number of events 2 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	5.9% 2/34 • Number of events 2 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	0.00% 0/23 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	4.5% 2/44 • Number of events 2 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	0.00% 0/23 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	2.3% 1/44 • Number of events 1 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	5.9% 2/34 • Number of events 2 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	4.3% 1/23 • Number of events 1 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	4.5% 2/44 • Number of events 2 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	0.00% 0/23 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.
Respiratory, thoracic and mediastinal disorders Pharyngeal erythema	0.00% 0/44 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	0.00% 0/34 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	8.7% 2/23 • Number of events 2 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	0.00% 0/44 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.	0.00% 0/23 • From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84. AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.

Additional Information

Dr. Gurdyal Kalsi

Emergent BioSolutions

Phone: 301-216-9927

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor is responsible for public disclosure of study data. Any proposed publication is subject to review agreed between the Division of Microbiology and Infectious Diseases (DMID) and Emergent; between Emergent and the contract research organizations (CROs)/vendors; and between the CROs and the site Principal Investigator. Data are the property of the sponsor and cannot be published without prior authorization from the sponsor, but data and publication thereof will not be unduly withheld.
Publication restrictions are in place

Restriction type: OTHER